Trial intelligence / Profile preview

Effect of Estetrol-drospirenone Combined Oral Contraceptive Pill on Arterial Vascular Risks

NCT07536763Phase 3

Key facts

Status: Not yet recruiting
Start: Jul 2026
Primary completion: Jun 2029
Modality: Small Molecules

Drugs: estetroldrospirenone
Conditions: contraceptionmenstrual disorders

Overview

Phase 3, randomised, open-label trial of estetrol and drospirenone in contraception and menstrual disorders (2 arms). Primary endpoint: Flow-mediated dilatation at 12 months. Planned start Jul 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedOpen-label

E4-drospirenone
Estetrol 15mg + drospirenone 3mg
EE-levonorgestrel
Ethinylestradiol 30mcg + levonorgestrel 150mcg

Who it enrols

Women aged 18-49 considering COC for contraception or menstrual disorders, excluding those with menopause, contraindications to COC (e.g., hypertension, diabetes with complications, history of ischemic heart disease, thromboembolism, stroke, severe liver disease, estrogen-sensitive cancers, undiagnosed abnormal uterine bleeding, smokers aged >=35, BMI >=35), planning pregnancy within 1 year, pregnant in past 3 months, or on specific medications in past 3 months.

Endpoints

Primary

Flow-mediated dilatation12 months

Secondary

Pulse wave velocity12 months
Body mass index12 months
Waist-hip ratio12 months
Blood pressure12 months
Sex hormone-binding globulin12 months
High sensitivity C-reactive protein12 months
Fasting glucose12 months
2-hour glucose12 months

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